Measures of Respiratory Health (MRH)

Name of Study: Measures of Respiratory Health (MRH)

Brief Summary: The Lung Clearance Index, measured by multiple breath washout, is a measure of lung function that is considered a research tool in Canada as the device used to measure it is not approved by Health Canada. The study will assess lung function in patients undergoing routine lung function testing for clinical indications (Cystic Fibrosis and Other Respiratory Diseases). In addition, healthy controls of different ages will be asked to perform this lung function test to gain reference data that can be used to interpret LCI in patients with lung disease.

Intervention: This is an Observational study

Age range: 2.5 – 18 yrs

Criteria

Participants with CF

Inclusion criteria:

  1. 2.5 – 18 years of age at enrolment
  2. Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:
    1. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
    2. A documented genotype with two disease-causing mutations in the CFTR gene
  3. Informed consent by participant, parent, or legal guardian
  4. Ability to perform technically acceptable MBW measurements

Exclusion criteria:

  1. Physical findings at screening that would compromise the safety of the participant as judged by the patient’s most responsible physician
  2. The requirement of supplementary oxygen to maintain an oxygen saturation above 95%

Participants with another respiratory disease

Inclusion criteria:

  1. MD diagnosed lung disease and/or attending the Pulmonary Function Laboratory
  2. 2.5 – 18 years of age at enrollment
  3. Informed consent by participant, parent, or legal guardian
  4. Ability to perform technically acceptable MBW measurements

Exclusion criteria:

  1. Physical findings at screening that would compromise the safety of the participant or the quality of the study data.
  2. The requirement of supplementary oxygen to maintain an oxygen saturation above 95%

Healthy Participants

Inclusion criteria:

  1. 2.5 – 30 years of age at enrollment
  2. Informed consent by participant, parent, or legal guardian
  3. Ability to perform technically acceptable MBW measurements

Exclusion criteria:

  1. Physical findings at screening that would compromise the safety of the participant or the quality of the study data.
  2. Evidence of a chronic disease process such as lung disease

Sites in Ontario:

The Hospital for Sick Children, Toronto, ON

Contact: Felix Ratjen, MD Ph.D. Email: felix.ratjen@sickkids.ca

Sub-Investigator: Hartmut Grasemann, MD PhD

Sub-Investigator: Sanja Stanojevic, PhD

Status: Recruiting

Click here for more information about this study

Source: clinical trials.gov Identifier #: NCT02657837

Last updated: May 31st, 2018

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